The present invention is directed toward an immunoassay test device and more particularly, toward a test device incorporating test strips in the cap of a test sample container.
Fluid test samples, for example urine or other bodily fluids, are often collected in containers or cups with lids. When a test is to be run on the sample, the lid is either punctured, removed, or otherwise penetrated in order to remove the fluid therefrom to a test device. The problem with this type of collection device is that the likelihood of the test sample spilling and contaminating the user is very high.
Another type of test device involves placing a test strip with test reagents contained therein directly into the test sample. Again, the risk of contamination is high. In this test, however, it is the test sample that can be contaminated. Thus, the test results may be inaccurate. Another problem with this type of device is that the test strip may become saturated to the point where the test strip cannot be read.
Some patents have addressed the problems discussed above and have proposed solutions. For example, U.S. Pat. No. 5,403,551 to Galloway discloses a container with a front wall that includes a plurality of test strips. A series of passageways in the device allows liquid within the container to wet a portion of the test strips when the container is inverted in order to perform an analysis. With this device, however, there is a possibility of leakage when the container is inverted, thereby leading to possible contamination. Furthermore, the test strip may be saturated too much or not enough, thereby leading to inaccurate test results.
U.S. Pat. No. 5,119,830 to Davis discloses an analytical specimen cup that houses a test sample. A testing means includes a cup and a lid. The lid includes a number of test strips for providing a visual indication of a variety of different test results. The lid is secured to the container. In order to use the device, the container is tilted so that the test sample enters a portion of the lid and activates the test. Again, this device requires that the container be tilted in order for the sample to contact the test strips. Thus, there is a possibility of contamination and inaccurate results as discussed above.
Likewise, U.S. Pat. No. 4,976,923 to Lipsky et al. discloses a fluid test apparatus that includes a container and a cover. The cover is screwed onto the container. The cover contains reagents and holes through which the test sample reaches the reagents when the container is inverted.
Therefore, a need exists for test sample collection device that allows for a test to be conducted within the collection device without having to transfer the test sample and that allows the test to be conducted without having to invert or otherwise disturb the container of the collection device.